Rep. Tom Graves on Tuesday voted for and the House passed the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act (S. 204), bipartisan legislation to expand access to drugs currently undergoing clinical trial for patients who exhaust approved treatment options.
"We all know someone who was taken too soon by cancer, Alzheimer's or some other deadly disease,” said Rep.
Graves. “As President Trump said in his State of the Union Address this year, every terminally-ill patient should have the right to try innovative drugs that could save their lives. This bill will provide additional options and hope for Americans who exhaust all the conventional treatments.”
Specifically, S. 204 amends the Federal Food, Drug, and Cosmetic Act to exempt certain drugs for terminally-ill patients who unsuccessfully utilized approved treatment options and are unable to participate in clinical trials involving the drugs.
Further, S. 204 requires manufacturers and sponsors of eligible unapproved drugs to report annually to the Food and Drug Administration (FDA) on the use of these drugs and requires the FDA to post annual summary reports online.
The bill will now go to the president to be signed into law.